U.S. patent application number 12/068783 was filed with the patent office on 2008-08-14 for orthopedic brace including a protector assembly.
Invention is credited to Palmi Einarsson, Arni Thor Ingimundarson.
Application Number | 20080195015 12/068783 |
Document ID | / |
Family ID | 39686471 |
Filed Date | 2008-08-14 |
United States Patent
Application |
20080195015 |
Kind Code |
A1 |
Ingimundarson; Arni Thor ;
et al. |
August 14, 2008 |
Orthopedic brace including a protector assembly
Abstract
A patella protector assembly for use with an orthopedic device,
wherein the patella protector assembly has a central shell, an
upper shell slidably connected to the central shell, and a lower
shell slidably connected to the central shell. The central shell
includes a main shell and a flexible perimeter edge portion
surrounding at least a section of the perimeter of the main shell.
The perimeter edge portion has greater flexibility than the main
shell. The upper and lower shells are arranged pivotally and
telescopically relative to the central shell such that the central,
upper and lower shells together form a continuous shell without
gaps therebetween.
Inventors: |
Ingimundarson; Arni Thor;
(Ladera Ranch, CA) ; Einarsson; Palmi; (San Juan
Capistrano, CA) |
Correspondence
Address: |
BACON & THOMAS, PLLC
625 SLATERS LANE, FOURTH FLOOR
ALEXANDRIA
VA
22314
US
|
Family ID: |
39686471 |
Appl. No.: |
12/068783 |
Filed: |
February 12, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60900719 |
Feb 12, 2007 |
|
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|
Current U.S.
Class: |
602/26 ;
602/23 |
Current CPC
Class: |
Y10T 24/21 20150115;
A61F 2005/0181 20130101; A41D 13/065 20130101; A61F 5/01 20130101;
A61F 5/0123 20130101 |
Class at
Publication: |
602/26 ;
602/23 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1. A patella protector assembly, comprising: a central shell
defining front and rear surfaces, and having a main shell and a
flexible perimeter edge portion surrounding at least a section of
the perimeter of the main shell, the perimeter edge portion having
greater flexibility than the main shell; an upper shell slidably
connected to the central shell; and a lower shell slidably
connected to the central shell; wherein upper and lower shells are
arranged telescopically relative to the central shell such that the
central, upper and lower shells together form a continuous shell
without gaps therebetween.
2. The patella protector assembly according to claim 1, further
comprising an elongate buttress secured to and protruding outwardly
from the front surface of the central shell.
3. The patella protector assembly according to claim 2, wherein the
central shell has an arcuate cross-section, and the upper and lower
shells have arcuate cross-section corresponding in shape to the
cross-section of the central shell.
4. The patella protector assembly according to claim 3, wherein the
upper and lower shells are pivotally mounted to the central
shell.
5. The patella protector assembly according to claim 1, wherein the
central shell has a plurality of apertures arranged a predetermined
pattern.
6. The patella protector assembly according to claim 1, wherein
central shell defines a plurality of elongate ribs formed and
protruding outwardly from a front surface and extending
longitudinally across at least a portion of the central shell.
7. The patella protector assembly according to claim 1, wherein the
perimeter edge portion defines opposed wings extending laterally
relative to a longitudinal axis of the central shell and being
resilient to twisting.
8. The patella protector assembly according to claim 1, wherein the
main shell is interlockingly molded onto the peripheral edge
portion such that the main shell is inseparably secured to the
peripheral edge portion.
9. The patella protector assembly according to claim 1, wherein the
upper and lower shells include a main body and a peripheral edge
portion interlocking with the main body, the peripheral edge
portion having a greater flexibility than the main body.
10. The patella protector assembly according to claim 1, wherein
the upper shell includes a shell retention element secured within a
slot formed through the central shell, the shell retention element
permitting close sliding of the upper shell relative to the central
shell.
11. The patella protector assembly according to claim 10, wherein
the shell retention element includes an arcuate neck extending from
a body portion of the upper shell, and a cross-bar connected to the
neck, the cross-bar oriented perpendicularly relative to the
slot.
12. The patella protector assembly according to claim 1, wherein
the lower shell has a shell retention element located at one end
thereof, the shell retention element connected to the central
shell, and permitting close sliding and pivoting of the lower shell
relative to the central shell.
13. The patella protector assembly according to claim 1, further
comprising a padding liner secured to each of the rear surface of
the central shell, and the upper and lower shells, the central
shell having a plurality of apertures.
14. A patella protector assembly, comprising: a central shell
defining front and rear surfaces, and forming a centrally located
elongate slot; a supplementary shell slidably and pivotally
connected to and along the rear surface of the central shell, the
supplementary shell including a shell retention element located at
a first end thereof, the shell retention element slidably and
pivotally connected to the central shell via the elongate slot
thereby permitting close sliding and pivoting of the corresponding
shell relative to the rear surface of the central shell.
15. The patella protector assembly according to claim 14, further
comprising an elongate buttress secured to and protruding outwardly
from the front surface of the central shell, the buttress having a
greater toughness than the central shell.
16. The patella protector assembly according to claim 14, wherein
the central shell includes a peripheral edge portion defining
opposed wings extending laterally relative to a longitudinal axis
of the central shell and being resilient to twisting.
17. The patella protector assembly according to claim 16, wherein
the wings each define a central opening.
18. The patella protector assembly according to claim 14, wherein
the central shell includes a rigid main shell and a flexible
peripheral edge portion surrounding about at least a section of the
perimeter of the main shell, the peripheral edge portion having
greater flexibility than the main shell.
19. The patella protector assembly according to claim 14, wherein
the central shell and the supplementary shell are formed with
corresponding cross-sectional profiles permitting pivoting of the
supplementary shell to at least 45.degree. relative to the central
shell without interference.
20. An orthopedic brace, comprising: a frame having proximal and
distal frame portions connected by lateral and medial hinges; a
protector assembly including: a central shell defining front and
rear surfaces, and having a rigid main shell and a flexible
peripheral edge portion surrounding at least a section of the
perimeter of the main shell, the peripheral edge portion having
greater flexibility than the main shell, the central shell
connected to the proximal and distal frame portions and secured to
the lateral and medial hinges; wherein the peripheral edge portion
defines opposed wings extending laterally relative to a
longitudinal axis of the main shell, the opposed wings secured to
the at least one hinge and arranged to resiliently twist relative
thereto; wherein the wings each define a central opening arranged
for securing about the at least one hinge.
Description
[0001] This application claims the benefit of priority from U.S.
provisional application 60/900,719 filed on Feb. 12, 2007.
TECHNICAL FIELD
[0002] The present invention generally relates to orthopedic
braces, and more particularly to a patella protector assembly for
use with the orthopedic brace having telescoping shells.
BACKGROUND
[0003] Orthopedic braces comprise a broad range of structures and
devices used for supporting or stabilizing a joint when worn on the
body of a user. Orthopedic braces may serve in either preventative
or remedial roles. In the preventative role, the brace can provide
additional support, stability and protection to a healthy joint so
as to prevent or minimize injury to the joint due to undue stress.
On the other hand, in the remedial role, the brace can support and
strengthen a weakened joint due to injury or infirmity, and thereby
reinforce the joint to prevent further injury, or correct or assist
the infirmity.
[0004] Typically, orthopedic braces include a frame that comprises
at least one support member. When there are multiple support
members, the brace may include rotational hinges that assist and
control movement of the limb. Suitable straps may be used to
maintain the brace on the limb, and other features such as pads may
be used to relieve pressure of the brace on the limb and
surrounding areas.
[0005] A predominant type of orthopedic brace is a knee brace. Knee
braces are used to stabilize the knee by preventing excessive
movement of the knee, or to facilitate movement of the knee. Many
braces comprise a frame and have hinges located on at least one of
the lateral and medial sides of the knee joint. Straps are used to
secure the brace to the leg or knee. An injured knee can be fit
with an "off the shelf" brace or a "custom-fit" brace, with the
selection of the type of brace depending on the size and shape of
an individual's leg.
[0006] Many knee braces are designed to reduce knee instability
following an injury, fatigue or to treat impairment of the knee,
particularly if the knee has damaged ligaments. Braces may be
recommended for walking, skiing, running, twisting, pivoting, or
jumping activities. In addition to providing increased stability to
the knee, braces may also decrease the risk of injuring the knee or
leg, or provide corrective assistance to the knee. One way of
protecting the knee is by including attachments such as a patella
protector assembly which may be secured onto the brace and
configured to operate to protect the patella impact during physical
activities.
[0007] In order to maximize its supportive, protective and comfort
aspects, it is desirable that a knee brace securely and precisely
fit the leg of the wearer. While custom-fit braces are made to
closely conform to the exact geometry of a leg of a wearer, it is
common for the geometry of the leg to change over time thereby
requiring even a custom-fit to be able to accommodate a variety of
geometries of the leg. As for off-the-shelf braces, these braces
must be configurable to generally accommodate a variety of leg
geometries irrespective of the particular geometry of a leg.
[0008] In recognizing the need for effective knee braces, various
knee braces have been introduced into the marketplace. Such knee
braces, however, have generally comprised relatively heavy, bulky
apparatuses that fail to provide ventilation and evenly distribute
pressure from the brace on the leg of the wearer. Moreover, many
contemporary braces are deficient in that the braces are
constructed in a manner that do not consistently provide or lack
adjustment features for forming a firm, comfortable and secure
interface between the leg and knee of the wearer and the brace. As
a result of these drawbacks, many knee braces detract from the
user's endeavor.
[0009] The features of the present invention are provided in
recognition of the need for orthopedic braces and components for
use therewith that are adjustable in both custom-fit and
off-the-shelf braces so as to achieve superior functional
performance characteristics while being comfortable to the wearer
when worn. This recognition is realized with the invention
described hereinafter.
SUMMARY
[0010] This disclosure describes an orthopedic brace and components
for use therewith. In accordance with one of the exemplary
embodiments described herein, a component is in the form of a
patella protector assembly including a central shell defining front
and rear surfaces, and is comprised of a main shell and a flexible
perimeter edge portion surrounding at least a section of the
perimeter of the main shell. The edge portion has a greater
flexibility than the main shell. Supplementary shells are used in
combination with the central shell such including an upper shell
slidably and pivotally connected to the central shell, and a lower
shell likewise slidably and pivotally connected to the central
shell. The upper and lower shells are arranged telescopically
relative to the central shell such that the central, upper and
lower shells together form a continuous shell without gaps
therebetween.
[0011] The embodiment may further include an elongate buttress
secured to and protruding outwardly from the front surface of the
central shell. The central shell may form a plurality of apertures
arranged in a predetermined pattern and define a plurality of
elongate ribs formed and protruding outwardly from a front surface
and extending longitudinally across at least a portion of the
central shell.
[0012] The central shell may have an arcuate cross-section, and the
upper and lower shells may further define an arcuate cross-section
closely corresponding in shape to the cross-section of the central
shell. The central shell and the supplementary shells are formed
with corresponding cross-sectional profiles permitting pivoting of
the supplementary shells to at least 45.degree. relative to the
central shell without interference. This configuration allows for
the upper and lower shells to be preferably pivotally mounted to
the central shell without forming any substantial gaps
therebetween, and to closely track movement of the leg anatomy.
[0013] The perimeter edge portion of the central shell may define
opposed wings which extend laterally relative to a longitudinal
axis of the central shell and are resilient to twisting when
mounted on an orthopedic brace. The main shell is interlockingly
molded onto the peripheral edge portion such that the main shell is
inseparably secured to the peripheral edge portion. Further, the
upper and lower shells may include a main body and a peripheral
edge portion interlocking with the main body, the peripheral edge
portion having a greater flexibility than the main body.
[0014] In accordance with one embodiment, the upper shell includes
a shell retention element secured within a slot formed through the
central shell. The shell retention element permits close sliding of
the upper shell relative to the central shell. The shell retention
element may define an arcuate neck extending from a body portion of
the upper shell, and a cross-wise pin or bar connected to the neck.
The cross-wise pin is preferably oriented perpendicularly relative
to the slot. For example, the lower shell has a shell retention
element located at one end thereof and the shell retention element
is connected to the central shell. The shell retention element
permits close sliding and pivoting of the lower shell relative to
the central shell.
[0015] The features described herein in connection with the
exemplary embodiments enable significant improvements to orthopedic
devices, such as knee braces, in the way of improved stability,
fit, weight, comfort and appearance. The subshells allow for a
considerable reduction in weight and provide close compliance to
the anatomy of the wearer. This results in a comfortable device
that is particularly less bulky and easily ventilated and further
allowing for better suspension on the leg anatomy. These
advantageous features combine to form a streamlined device allowing
the wearer greater freedom, flexibility and stability of the
anatomy when the device is worn. For example, the construction of
these features allows for a device in which straps may be mounted
under frame elements for better soft tissue containment and a more
intimate fit. Further, the subshells have an appearance in
combination with an overall streamlined set of features, which make
the device more enticing to wear over prior art braces so as to
better assure patient compliance in wearing the brace.
[0016] These and other features, aspects, and advantages of the
present invention will become better understood with regard to the
following description, appended claims, and accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 is a perspective view of an embodiment of an
orthopedic brace.
[0018] FIG. 2 is a front elevational view of the brace according to
FIG. 1.
[0019] FIG. 3 is a rear elevational view of the brace according to
FIG. 1.
[0020] FIG. 4 is a plan view of an embodiment of a subshell used in
the orthopedic brace of FIG. 1.
[0021] FIG. 5 is a cross-section view taken along line V-V in FIG.
4.
[0022] FIG. 6 is a perspective view of another embodiment of an
orthopedic brace.
[0023] FIG. 7 is a front elevational view of the brace according to
FIG. 6.
[0024] FIG. 8 is a rear elevational view of the brace according to
FIG. 6.
[0025] FIG. 9 is a plan view of an embodiment of a subshell used in
the orthopedic brace of FIG. 6.
[0026] FIG. 10 is a perspective view of a variation of the subshell
of FIG. 9.
[0027] FIG. 11 is a perspective view of another variation of the
subshell of FIG. 9.
[0028] FIG. 12 is a perspective view of another embodiment of a
shell employing certain features of FIG. 11.
[0029] FIG. 13 is a top plan view of an embodiment of a strap
retainer.
[0030] FIG. 14 is a bottom plan view of an embodiment of the strap
retainer of FIG. 13.
[0031] FIG. 15 is front perspective view of the strap retainer of
FIG. 13 with a peripheral edge portion.
[0032] FIG. 16 is a rear perspective view of the strap retainer of
FIG. 13.
[0033] FIG. 17 is a perspective view of a strap pad for use with
the strap retainer of FIG. 13.
[0034] FIGS. 18 and 19 are schematic views of a fastener retainer
in the frame of the orthopedic brace of FIG. 1.
[0035] FIG. 20 is an elevational view of an embodiment of a
fastener retainer.
[0036] FIG. 21 is a front elevational view of a patella protector
assembly in an extended configuration for use on the brace of FIG.
6.
[0037] FIG. 22 is a rear elevational view of the patella protector
assembly in FIG. 21.
[0038] FIG. 23 is an exploded assembly perspective view of the
patella protector assembly of FIG. 21.
[0039] FIG. 24 is a rear elevational view of a buttress depicted in
FIG. 23.
[0040] FIG. 25 is a schematic view of the patella protector
assembly of FIG. 21 on the brace of FIG. 6 when a leg is in
extension.
[0041] FIG. 26 is a schematic view of the patella protector
assembly of FIG. 21 on the brace of FIG. 6 when a leg is in
flexion.
DESCRIPTION OF VARIOUS EMBODIMENTS
A. Overview
[0042] A better understanding of different embodiments of the
invention may be had from the following description read in
conjunction with the accompanying drawings in which like reference
characters refer to like elements.
[0043] While the disclosure is susceptible to various modifications
and alternative constructions, certain illustrative embodiments are
shown in the drawings and are described below in detail. It should
be understood, however, that there is no intention to limit the
disclosure to the specific embodiments disclosed, but on the
contrary, the intention is to cover all modifications, alternative
constructions, combinations, and equivalents falling within the
spirit and scope of the disclosure.
[0044] It will be understood that, unless a term is expressly
defined in this patent to possess a described meaning, there is no
intent to limit the meaning of such term, either expressly or
indirectly, beyond its plain or ordinary meaning.
[0045] Any element in a claim that does not explicitly state "means
for" performing a specified function, or "step for" performing a
specific function, is not to be interpreted as a "means" or "step"
clause as specified in 35 U.S.C. .sctn.112, paragraph 6.
B. Environment and Context of Embodiments
[0046] Numerous orthopedic brace embodiments and components (e.g.,
subshells and strap retainers) for use therewith are described
herein, with particular focus given to braces and components
directed to the knee joint and surrounding areas. The orthopedic
brace embodiments may serve in protective, preventative or remedial
capacities. While the orthopedic brace is described within the
context of a preferred embodiment that is directed to securing the
knee joint, many of the features described herein may be extended
to orthopedic braces and components that secure other joints and
body parts, such as the wrist, elbow, shoulder, ankle and neck.
[0047] The brace embodiments and components for use therewith may
be dimensioned to accommodate different types, shapes and sizes of
human joints and appendages. In addition, embodiments may be
modified to orient principal forces exerted by strap systems of the
embodiments at any desirable location to secure the brace onto a
leg in order to stabilize the knee.
[0048] The knee joint comprises two joints, lateral and medial,
between the femur and tibia, and one arthrodial joint between the
patella and femur. The primary movements of the knee comprise
flexion, i.e., rearward rotational movement of the tibia relative
to the femur, and extension, i.e., forward rotational movement of
the tibia relative to the femur.
[0049] For explanatory purposes, each orthopedic brace embodiment
or component thereof described herein may be divided into sections
which are denoted by general anatomical terms for the human body.
Such anatomical terms are provided to distinguish various elements
of the brace embodiments from one another, but which are not to be
considered to limit the scope of the invention.
[0050] Each of these terms is used in reference to a human leg, by
way of example, which is divided in similar sections with a
proximal-distal plane generally extending along the meniscus of the
knee between the femur and tibia. The terms "proximal" and "distal"
generally refer to locations of the brace that correspond to the
location of leg relative to the point of attachment of the leg to
the body. The terms "upper" and "lower" may be used in combination
with "proximal" and "distal" to connote gradations in location of
"proximal" and "distal." The location at where the brace
corresponds to the knee joint is used herein to generally delimit
the proximal and distal sections of the brace.
[0051] The embodiments of the knee brace can also be considered to
fall within "anterior" and "posterior" sections by an
anterior-posterior plane. The anterior-posterior plane generally
corresponds to the coronal or frontal plane of a human leg which
lies along the central longitudinal axis of a body. A posterior
side or element is therefore located behind this anterior-posterior
plane, whereas an anterior side or element is located in front of
the anterior-posterior plane.
[0052] The terms "inwardly" or "inner" commonly used herein to
distinguish the side of the brace that may be directed to the
posterior side of the brace and specifically adjacent to the leg of
the wearer of the brace. Contrariwise, the term "outwardly" or
"outer" are used to denote the side of the brace that is opposite
to the inwardly side.
[0053] The terms "medial" and "lateral" are relative terms that are
generally understood as indicating location near the midsaggital
plane or midline. Therefore, elements that are located near the
midline are referred to as "medial" and those elements that are
further from the midline are considered to be "lateral." The term
"central" is used to denote the area along the midline of a joint
thereby dividing and sharing regions of the medial and lateral
regions.
[0054] From these terms, it follows that the anterior section of
the brace has the following quadrants: (I) proximal-medial, (II)
distal-medial, (III) distal-lateral, and (IV) proximal-lateral. The
posterior section of the brace has the following quadrants: (V)
proximal-medial, (VI) distal-medial, (VII) distal-lateral, and
(VIII) proximal-lateral. Structural members and features thereof
will fall within one of the quadrants is specifically referenced in
relation to such quadrant, either in its entirety or partially.
[0055] The terms "rigid" and "flexible" are repeatedly used herein
to distinguish characteristics of portions of the brace. The term
"rigid" is intended to denote that the frame is generally devoid of
flexibility. Within the context of frame members that are "rigid,"
it is intended to indicate that they may break if bent with
sufficient force. On the other hand, the term "flexible" is
intended to denote that features are capable of repeated bending.
The term "resilient" is used to qualify such flexible features as
generally returning to the initially molded shape with permanent
deformation.
[0056] The anatomical and characteristic terms described herein are
not intended to detract from the normal understanding of such terms
as readily understood by one of ordinary skill in the art of
orthotics. Moreover, the elements of the embodiments described
herein are intended to embrace embodiments that generally
correspond to the aforementioned anatomical sections. In other
words, it is understood that the elements of the brace embodiments
described herein may deviate from falling exactly within the
confines of the aforementioned anatomical sections.
C. Various Embodiments of the Orthopedic Brace and Components for
Use Therewith
[0057] In observing FIGS. 1-3, an embodiment of the orthopedic
brace is shown and generally designated 10. For explanation
purposes, the orthopedic brace 10 is a knee brace configured for
securing to a right leg of a user. Nonetheless, it is readily
apparent to the skilled artisan from the discussion herein that the
orthopedic brace and particular features thereof of the present
invention may be adapted to be secured to a left leg or other parts
of the body to treat skeletal joints apart from the knee.
[0058] The orthopedic brace 10 comprises a substantially rigid
frame 12 including proximal and distal frame assemblies 14, 16, a
substantially flexible distal subshell 46, lateral and medial
central joints 18, 20, substantially flexible strap retainers 68,
70, 72, 78, padding, and a plurality of straps. For simplification,
the brace embodiments shown herein are depicted without their
specific straps and padding. A more detailed description of
possible configurations of the straps and the padding that may be
used in accordance with the orthopedic brace described herein is
provided in U.S. patent application publications 2006/0135900 and
2007/0185425, owned by the assignee of this disclosure and
incorporated herein by reference.
[0059] The frame 12 includes a proximal frame assembly 14, a distal
frame assembly 16, and lateral and medial joints 18, 20. The
proximal frame assembly 14 comprises in combination a lower
proximal-lateral longitudinal support 22, lower proximal-medial
longitudinal support 24, proximal-central support 26,
proximal-central stem 28, and upper proximal-lateral support 30.
The distal frame assembly 16 comprises in combination an upper
distal-lateral support 34, upper distal-medial support 36,
distal-central support 38, distal-central stem 40, and lower
distal-lateral support 42.
[0060] The proximal and distal frame assemblies 14, 16 preferably
have arcuate configurations which are arranged to accommodate the
contours of a leg. For example, the upper proximal-lateral support
30 and the lower distal-lateral support 42 each include cuff
sections 32, 44, respectively, that are intended to conform to
lateral aspects of the proximal and distal portions of the leg when
the brace is placed on the leg of the user. According to the
embodiment of FIGS. 1-3, the proximal and distal frame assemblies
do not yield to the contours of the leg but instead are preformed
to a particular shape that accommodates the leg. When worn, the
proximal and distal frame assemblies 14, 16 are intended to be
shaped so as to closely trace and secure to the leg.
[0061] The proximal and distal frame assemblies 14, 16 are each
preferably constructed from a unitary or continuous rigid piece of
material. In other words, by way of example in reference to the
proximal frame assembly 14, the lower proximal-lateral longitudinal
support 22, lower proximal-medial longitudinal support 24,
proximal-central support 26, proximal-central stem 28, and upper
proximal-lateral support 30 continuously merge into one another.
The distal frame assembly 14 is similarly configured to the
proximal frame assembly 16.
[0062] The frame 12 is preferably characterized herein as being
substantially rigid. The rigidity of the frame is generally the
result of both the material from which the frame is constructed and
its geometry. The material and geometry of the proximal and distal
frame assemblies 14, 16 are generally rigid along the entirety of
their length such that rigidity of the frame assemblies has a
generally high and uniform rigidity. Exemplary materials that may
be used for constructing the frame include metals such as aluminum,
titanium, and steel, thermoset resin composite systems including
glass or carbon fibers, and thermoplastics that have been rendered
rigid by way of material composition and geometry of the frame
members.
[0063] It will be noted that the requirement that the frame 12 has
substantially rigid properties is provided only as an exemplary
configuration. It will be noted that the frame may have flexible
properties, and may further be provided in discrete segments such
that the proximal and distal frame assemblies are segmented as
opposed to continuous, and may be connected to one another by
suitable hinges, fasteners or other suitable elements.
[0064] The proximal and distal frame assemblies 14, 16 are
connected to one another by the lateral and medial joints 18, 20.
The lateral joint 18 connects the lower proximal-lateral
longitudinal support 22 to the lower distal-lateral longitudinal
support 34, and similarly the medial joint 20 connects the lower
proximal-medial longitudinal support 24 and the upper medial-upper
longitudinal support 36. The ends of the longitudinal supports 22,
24, 34, 36 are configured to cooperatively engage the lateral and
medial joints 18, 20.
[0065] The lateral and medial joints 18, 20 are preferably
rotational hinges, which rotationally connect the proximal frame
assembly 14 to the distal frame assembly 16. The lateral and medial
joints 18, 20 enable rotational displacement of the proximal-lower
lateral and medial longitudinal supports 22, 24 between positions
of extension and flexion. Suitable condoyle pads 58 may be used to
cover at least portions of the lateral and medial central joints
18, 20, and may be configured to be removable and replaceable.
[0066] The substantially flexible distal subshell 46 secures to a
posterior surface of the frame 12. The distal subshell 46 connects
to the distal-central support 38 and the distal-central stem 40 via
fasteners through apertures 92. The distal subshell 46 projects and
depends freely from the frame 12 so as to extend into the medial
side of the brace and be located lower from the distal medial
longitudinal support 36. In effect, the distal medial subshell 46
is a counterpart to the lateral lower support 42; however it is
significantly flexible, resilient and durable.
[0067] These features and those described that follow, are not
limited to a "distal" subshell, but may be extended to a subshell
located at any location in an orthopedic device. In other words,
any of the subshells described herein are not limited in structure
and location with regard to their exemplary embodiments; they may
be modified and located at any suitable location in an orthopedic
device.
[0068] According to the embodiment of FIGS. 1-3, the distal
subshell 46 is defined, at least in part, by a main body 48. The
main body 48 includes a central end region 52 that secures to the
distal-central support 38 and the distal-central stem 40, a medial
end region 56, and an intermediate section 54 that connects the
central end region 52 to the medial end region 56. As depicted in
FIGS. 2-3, the intermediate portion 54 may be narrower than the
central and medial end regions 52, 56. The medial end region 56 is
generally enlarged so as to conform to the medial aspect of the
lower portion of the user's leg when the orthopedic brace is placed
upon the leg of the user. A significant advantage to the subshell
is that it can be sized to cover a broad portion of the anatomy of
the leg to more effectively and comfortably secure (by distributing
forces) the brace to the leg without appreciably adding to the
weight of the brace.
[0069] The distal subshell 46 has a ventilation feature 53 in the
form of elongate slots that may extend or be located anywhere on
the main body 48 and be arranged in a configuration which
facilitates the passage of air through the subshell 46. At least
one of the slots 53 defines a strap slot 51 that may be used to
secure a strap 66 thereto that connects to a corresponding side of
the lower distal-lateral support.
[0070] The distal subshell 46 may be used in combination with an
apertured or ventilated padding that may be shaped to accommodate
the subshell, or have any other suitable configuration defining a
padding feature. While a preferred type of padding is described by
way of the spacer elements in U.S. patent application publications
2006/0135900 and 2007/0185425, other padding can be used that may
or may not be ventilated.
[0071] In the embodiment of FIGS. 1-3, the subshell 46 is
substantially more flexible than the substantially rigid frame 12.
For example, while the rigid frame 12 does not yield to the leg
when worn, the subshell 46 is flexible so as to bend so as to
conform to the leg thereby improving comfort to the wearer and
further distributing forces exerted onto the leg.
[0072] A distinguishing feature of the subshell 46 is that it
includes a pressure-relieving perimeter edge portion 50. The
pressure-relieving perimeter edge portion 50 is distinguished from
the main body 46 in that it preferably has a softer texture. More
specifically, the perimeter edge portion 50 has a hardness that is
lower than the hardness of the main body 46.
[0073] According to one variation, the main body 46 and the
perimeter edge portion 50 are formed from materials having
different hardnesses. In this variation, the main body 46 and the
perimeter edge portion 50 are injection molded thermoplastics that
are integrally molded together. An exemplary combination of
materials comprises thermoplastic polyurethane elastomers sold
under the name ELASTOLLAN by BASF group.
[0074] In making the subshell of this variation, the main body is
first fabricated by being formed by a first mold. A first material,
such as ELASTOLLAN S60D53N, is injected into the mold so as to
result in the formation of the main body. The molded main body is
then transferred to another, larger second mold which forms the
shape of the definitive subshell including the perimeter edge
portion. The main body is secured and centered in the second mold.
A second material, such as ELASTOLLAN C60A10W, is injected into the
second mold so as to contact the main body and form the perimeter
edge portion therearound. Due to the similarity in composition of
the first and second materials, the second material of the
perimeter edge portion bonds to the first material of the main body
as it is formed in the second mold. In this variation, the first
material has a hardness that is greater than the second
material.
[0075] A significant advantage to this variation of the subshell is
that the combination of a flexible subshell with or without a soft
perimeter edge portion provides a substantially comfortable feature
to the orthopedic brace. Unlike conventional braces, the distal
subshell yields to the shape of the leg while retaining the strap
and the perimeter edge portions relieves pressure along the edges
of the subshell. This allows for better soft tissue containment and
an intimate fit thereby providing the wearer enhanced freedom and
flexibility when wearing a device having the subshells. This also
leads to better suspension of the device having the subshell on
wearer's anatomy, which assists in maintaining the device in the
position to optimize bracing. Added with the ventilation feature,
for example the type described in U.S. patent application
publication 2006/0135900, the orthopedic brace provides a feature
that reduces bulk weight and size of known subshells or braces in
general, and facilitates breathability of the brace.
[0076] Another advantage to this variation of the subshell results
in eliminating the need to configure the subshell in a manner that
would include portions for receiving the perimeter edge portion. As
such, the main body may be molded with a perimeter edge portion
that does not include ledges, slots or grooves for receiving the
subsequently molded second material forming the definitive
perimeter edge portion. This provides a generally continuous
structure without gaps, raised areas, sharp edges and other
protuberances or recesses that may cause discomfort to the wearer
of the brace.
[0077] Another advantage to this variation of the subshell is that
the subshell and the perimeter edge portion, being continuous with
the main body, may be pigmented in a different color from the main
body. This provides an appearance resulting in a piping around the
periphery of the subshell which conveys a visually pleasing
appearance. For example, the first material used for forming the
main body of the subshell may have a black pigment, whereas the
second material used for forming the perimeter edge portion may
have a gray pigment.
[0078] The appearance of the subshells may be important, in
additional to their beneficial functional characteristics, in that
they may make the brace more enticing to wear so as to assure
better patient compliance of an orthopedic device having the
subshells. As readily apparent from the description on the
structure of the subshells, they allow for more streamlined
orthopedic devices due to their thin profile and their ability to
sufficiently conform to the anatomy of the wearer while assisting
to provide superior suspension of the device on the wearer.
Moreover, the ornamental appearance, made possible in part by the
piping and the slots, make it more desirable for the wearer to wear
the device over orthopedic devices having less than desirable
aesthetic qualities. This in turns provides the medical
professional more assurance that the wearer will more fully comply
with the treatment prescriptions or requirements the device is
intended to treat.
[0079] Yet another advantage to this variation of the subshell is
that the strap slots may also include a perimeter edge portion that
is formed from a material that is substantially harder than the
material of the main body. Such a material, as with the first and
second materials of this variation, may again be of a similar
nature to the first and second materials, but of a composition that
has a greater hardness, so as to continuously bond with the
subshell and to form an integral subshell structure. This harder
material surrounding a main body is particularly useful to provide
enhanced durability (i.e., when a strap is arranged to rub against
the harder material).
[0080] It will be noted that it is preferable that the material of
the main body of the subshell has a toughness that can permit a
strap to be secured directly therewith. Such a feature therefore
allows the subshell to not only serve as a bracing feature for the
orthopedic brace, but also eliminates the need for additional strap
retainers to be secured to the subshell.
[0081] While similar materials are described in connection with
this variation, it will be noted that dissimilar materials may also
be used. For example, polyethylene, polyurethane and other
thermoplastics may be used for forming the main body, and suitable
materials such as vinyl, rubber or thermoplastic elastomers may be
used for forming the perimeter edge portion. Other methods for
forming the main body with the perimeter edge portion may be found
in U.S. Pat. Nos. 5,445,602 and 5,716,335, incorporated herein by
reference. Moreover, a soft flexible perimeter edge portion may be
mechanically adhered, such as an adhesive, to a subshell having
ledge, slotted or groove portions upon which the perimeter edge
portion may be adhered that does not interlock with any structure
of the main body of the subshell.
[0082] It will be pointed out that the perimeter edge portion is
merely an exemplary form of overmolding over a main body or base
shell. Indeed, the main body or base shell may include other areas
of overmolding, such as a center portion filling in an opening in
the base shell, to provide pressure relieving characteristics to a
shell. In another example, the material surrounding and forming
slots defining a ventilation feature of the subshells may comprise
an overmolded material that has different properties than a main
body or base shell. Such properties may not necessarily comprise
those having less hardness than the main body or base portion; for
example, such properties may be those having a greater resiliency
and hardness than the main body or base portion.
[0083] The strap retainers 68, 70, 72, 74, 76, 78, are formed
substantially as the distal subshell 46 in that the strap
retainers, by way of strap retainer 68, are substantially flexible
and are particularly mounted via a fastener that extends through
fastening aperture 90 of the strap retainer and secures to the
inwardly facing side of the frame 12. The strap retainer 68 also
includes a main body 80 formed from a first material that has a
greater hardness than a perimeter edge portion 82. The strap
retainer 68 also includes a strap slot 84, and at least one
ventilation feature 86 by way of a slot. The materials used for
forming the strap retainer 68, according to one variation, may be
the same materials used to form the exemplary distal subshell 46
(i.e., the first material for the main body 80, and the second
material for the perimeter edge portion 82).
[0084] Like the distal subshell 46, the strap retainer 68 is
configured to bend or conform to the contours of the leg of a
wearer of the orthopedic brace. Since the materials of the strap
retainer are flexible, and further because the strap retainer has a
ventilation feature, the strap retainer may be sized larger than
conventional D-rings or other strap retainers in orthopedic braces.
This allows for the strap retainer to distribute pressure on the
leg of the wearer of the brace over a greater area than in
conventional devices.
[0085] In addition to the pressure-relieving flexible perimeter
edge portion, the strap retainer has a thin profile. The thin
profile is partly attributed to the ability to size the strap
retainer larger than conventional attachment devices due to the
ventilation feature and the lightweight nature of the materials
used to form the strap retainer. The strap retainer may therefore
be secured on the inwardly facing side of the frame 12 which is an
advantage over conventional attachment devices since mounting such
devices on the inwardly facing side of the frame of a brace would
likely cause discomfort to the leg of the wearer because these
devices tend to be substantially rigid and bulky. The thin profile
of the strap retainer is also beneficial in that it may be used
with a pad, as depicted in FIG. 13, to provide an additional
comfort aspect that relieves pressure.
[0086] In a variation of the distal subshell depicted in FIGS. 1-3,
FIG. 4 illustrates a distal subshell 93 having a main body 94 and a
perimeter edge portion 95. Unlike the distal subshell 46, this
variation has a beveled perimeter edge portion 97 which corresponds
to the tibia portion of the wearer. Because the tibia is prone to
sensitivity, this beveled portion 97 allows for greater cushioning
from its transitional profile and the soft nature of the material
used to form the perimeter edge portion.
[0087] The distal subshell 93 also includes apertures 97 whereat a
harder and tougher material may be used in a surrounding portion 98
about the aperture 97. This provides for greater durability when
the material of the main body 94 may not be sufficiently strong to
withstand repeated movement or tensioning of the subshell about a
leg. The surrounding portion 98 may be molded over the main body 94
in accordance with any of the methods described herein.
[0088] FIG. 5 illustrates a cross-sectional view taken along line
V-V in FIG. 4. This cross-sectional view exemplifies how the main
body 94 may be formed with a ledge or similar feature 99 upon which
the material of the perimeter edge portion 97 is molded onto and
bonds with the material of the main body 94. The ledge 99 is not
limited to the configuration as shown herein but may comprise a
spline, slots (through which material molded thereover interlocks),
or other suitable arrangements which assure a secure interlocking
of material of the perimeter edge portion and the main body.
[0089] In another orthopedic brace embodiment 100 illustrated in
FIGS. 6-8, the brace 100 may have a configuration wherein the
proximal and distal subshells replace certain supports and strap
retainers described in combination with the orthopedic brace 10 of
FIGS. 1-3.
[0090] The frame 102 includes a proximal frame assembly 104, a
distal frame assembly 106, lateral joint 108, and medial joint 110.
The proximal frame assembly 104 is substantially rigid, as in the
frame assembly 14 of the brace embodiment 10, and comprises in
combination a proximal-lateral longitudinal support 112,
proximal-medial longitudinal support 114, lower proximal-central
support 116, and upper proximal-central support 118. The distal
frame assembly 106 comprises in combination a distal-lateral
support 120, distal-medial support 122, upper distal-central
support 124, and lower distal-central support 126. The lateral and
medial central joints 108, 110 operate in a similar manner to those
described in connection with the embodiment of FIGS. 1-3.
[0091] Similar to the brace embodiment 10, the proximal and distal
frame assemblies 104, 106 preferably have arcuate configurations
which are arranged to accommodate the contours of a leg. As with
the frame 12 of the orthopedic brace 10, the frame 102 is
preferably characterized herein as being substantially rigid.
Moreover, the proximal and distal frame assemblies do not yield to
the contours of the leg but instead are preformed to a particular
shape that accommodates the leg. When worn, the proximal and distal
frame assemblies are intended to be shaped so as to closely secure
to the leg.
[0092] The proximal and distal frame assemblies 104, 106 are also
each preferably constructed from a unitary or continuous rigid
piece of material. The upper proximal-central support 118, and the
lower distal-central support 126, each gradually taper as they
extend away from the lower proximal-central support 116, and the
upper distal-central support 124, respectively. Preferably, as
shown in FIGS. 6-8, the upper proximal-central support 118, and the
lower distal-central support 126 have arcuate profiles so as to
mitigate any sharp geometry that may pose uncomfortable to the
wearer of the brace, and to ease the pressure exerted onto the
femur and tibia, respectively while providing support to such areas
of the leg.
[0093] As with the brace 10 of FIGS. 1-3, the brace 100 includes
lateral and medial strap retainers 186, 188 that are pivotally
secured via connection points 190 to the proximal lateral and
medial longitudinal supports 112, 114. The strap retainers 186, 188
may have the same configuration as the strap retainers described in
connection with the strap retainers of brace 10.
[0094] The brace 100 includes a proximal subshell 128 that is
secured to the inwardly facing side of the frame 102 at the lower
and upper proximal-central supports 116, 118. The proximal subshell
128 includes lateral and medial sections 137, 138 that generally
extend from a center portion 142 that is secured to the lower and
upper proximal-central supports 116, 118. The lateral and medial
sections 137, 138 each include an intermediate portion 141 that
connects the center portion 142 to enlarged lateral and medial end
portions 143, 145, respectively.
[0095] The lateral and medial end portions 143, 145 are preferably
sized larger than the intermediate portion 141 so as to embrace a
greater portion of the lateral and medial aspects of the leg. The
lateral and medial end portions 143, 145 each include at least one
strap slot 134 for securing a strap 176 that extends between
lateral and medial end portions on the inwardly facing side of the
brace 100. The at least one strap slot 134 on both the lateral and
medial end portions 143, 145 effectively replaces the need for any
strap retainer. Due to the enlarged size of the lateral and medial
end portions 143, 145 in combination with the strap 176, the
pressure exerted onto a leg when the corresponding strap is
tightened is able to be distributed over a larger area than is
found in conventional braces.
[0096] As with the subshell 46 of the brace 10, the proximal
subshell 128 includes a main body 130 and a peripheral edge portion
132. While the main body 130 is preferably flexible, the peripheral
edge portion 132 is substantially flexible and has a hardness that
is less than a hardness of the main body. The proximal subshell 128
may be constructed in a similar manner as the subshell 46 of the
brace embodiment 10 of FIGS. 1-3.
[0097] Moreover, both the main body 130 and the peripheral edge
portion 132 of the proximal subshell 128 may extend beyond the
periphery of the lower and upper proximal-central portions 116, 118
so as to minimize or relieve any pressure exerted on the leg of a
wearer due to the rigidity of the lower and upper proximal-central
portions 116, 118.
[0098] The proximal subshell 128 includes a ventilation feature 136
that is exemplified by a plurality of slots. While other
configurations may be used in addition to the slots 136, this
particular configuration of FIGS. 6-8 allows for at least some of
the slots to be sized and configured to also receive the strap 176
in addition to the strap slot 134 to provide greater size
adjustment to the strap or allow for the strap to extend over a
greater portion of the subshell. The slots 136, or other
ventilation structure, may be used in combination with a textile or
foam pad, or a ventilated spacer element of the type described in
U.S. patent application publication 2006/0135900 and 2007/0185425.
The combination of the ventilation feature with a ventilated spacer
element enables the brace to be tailored so as to provide air
passage through the subshell to allow for a substantially
breathable portion of the brace.
[0099] While not shown, the proximal subshell may be mechanically
secured to the frame 102 by suitable fasteners or adhesives. In a
variation, the proximal subshell may be provided with different
apertures or slots which enable the subshell to be adjustable
relative to the upper frame assembly 104. Certain adjustability may
be related to the height of the subshell, varus and valgus
adjustment, and the ability to move freely up and down relative to
the upper frame assembly when the brace is worn. Various means for
providing adjustability for the proximal subshell 128 may be
similar to those used in adjusting a distal or tibial subshell 144
to the distal frame assembly 106 described hereafter.
[0100] The distal subshell 144 is secured to the inwardly facing
side of the frame 102 at the upper and lower distal-central
supports 124, 126. The proximal subshell 144 includes lower lateral
and medial sections 154, 162 that generally extend from a lower
central portion 158 that is immovably secured or anchored to the
lower distal-central support 126 by at least one fastener 159. The
lower lateral and medial sections 162, 154 each include a lower
intermediate portion 157, 156, respectively. As with the lateral
and medial end portions 137, 138 of the proximal subshell 128, the
lower lateral and medial sections 162, 154 each have enlarged
geometry relative to the intermediate portions 157, 156 so as to
embrace a greater portion of the lateral and medial aspects of the
leg.
[0101] The lower lateral and medial sections 162, 154 each include
at least one lower strap slot 150 for securing a strap 182 that
extends between the lower lateral and medial sections on the
posterior side of the brace 100. The lower lateral and medial
sections 162, 154 include a ventilation feature 152 by way of a
plurality of slots similar to those of the proximal subshell
128.
[0102] The distal subshell 144 also comprises an upper central
portion 160 that extends proximally from the lower central portion
158, and includes a concave arcuate crest section 161 that is
configured to conform to the tibia of the wearer of the brace 100.
Upper lateral and medial intermediate sections 166, 168 connect
respectively to upper lateral and medial sections 164, 170. Both
the lateral and medial sections 164, 170 include at least one upper
strap slot 151, and the ventilation feature 152. Moreover, both the
upper lateral and medial sections 164, 170 are enlarged relative to
the upper intermediate sections 166, 168.
[0103] Both the upper lateral and medial sections 164, 170 include
at least one upper strap slot 151 that connects the upper lateral
and medial sections via a strap 180. The upper lateral and medial
sections 164, 170 effectively serve as both a support for the
wearer of the brace and as strap retainers.
[0104] The upper lateral and medial sections 164, 170 are
adjustable relative to the lower frame assembly 106, and in
particular to the distal-lateral support 120, and distal-medial
support 122. FIGS. 6 and 8 illustrate the upper lateral and medial
sections that each define a slot 172 through which a corresponding
tightenable fastener 174 extends and secures to the distal-lateral
support 120, and distal-medial support 122, respectively.
[0105] In a variation, FIG. 9 shows a plurality of adjustment
apertures 208 which are spaced in a manner that incrementally
allows for adjustment of the upper lateral and medial sections 164,
170 relative to the distal lateral and medial supports 120, 122.
Such adjustment of the upper lateral and medial sections enable the
adjustment of the alignment of the distal subshell and may
contribute to an anterior or posterior force on the tibia. The
flexible nature of the subshell allows for compliance to the leg
anatomy throughout the range of adjustment.
[0106] As with the proximal subshell 128, the distal subshell 144
includes a main body 146 and a peripheral edge portion 148. While
the main body 146 is preferably flexible, the peripheral edge
portion 148 is substantially flexible and has a hardness that is
less than a hardness of the main body. The proximal subshell 144
may be constructed in a similar manner as the subshell 46 of the
brace embodiment 10 of FIGS. 1-3.
[0107] Both the main body 146 and the peripheral edge portion 148
of the distal subshell 144 may extend beyond the periphery of the
upper and lower distal-central portions 124, 126 so as to minimize
or relieve any pressure exerted on the leg of a wearer due to the
rigidity of the upper and lower distal-central portions 124,
126.
[0108] FIG. 9 shows a variation of a distal subshell 200 that may
replace the distal subshell 144 in the brace 100. The distal
subshell 200 includes a plurality of differently shaped ventilation
features 202, 204, 206 that correspond to different regions of the
distal subshell 200. It will be understood that the ventilation
features may be modified in a plurality of different configurations
and are not limited to those shown or discussed herein. Of course,
the ventilation features may be arranged so as to optimize or
facilitate the passage of air through the subshell and any padding,
liner or spacer element located between the leg and the
subshell.
[0109] The distal subshell 200 also includes apertures 210
surrounded by recesses 212 for receiving fasteners that are used
for securing the distal subshell 200 to the lower distal-central
portion 126 of the brace 100. It will be pointed out that there are
preferably, while not limited thereto, apertures and recesses for
receiving fasteners defined on the distal subshell 200 that
correspond to the upper distal-central portion 124. This is so the
upper lateral and medial sections 164, 170 may be adjusted relative
to the distal lateral and medial supports 120, 122, respectively,
via the plurality of adjustment apertures 208.
[0110] FIG. 10 illustrates a variation of an orthotic or subshell
230 having a main body 146 configuration similar to the distal
subshell 200. The distal subshell 230 includes a peripheral edge
portion 148 that forms a lip 232 that extends over one surface of
the main body 146. A groove or clearance 234 is defined between the
lip 232 and the surface of the main body 146 generally about the
periphery of the main body 146. While the peripheral edge portion
is described as having one lip extending over a first side of the
main body, it will be noted that the peripheral edge portion may
form lips located over opposed sides of the main body, thereby
forming clearances between the lips and such surfaces.
[0111] The combination of the groove and the lip 232, 234 defines a
retaining structure or pocket for receiving a pad or spacer element
having a similar profile to that of the main body 146. The
peripheral edge portion is preferably formed from a resilient
material so that such lips may clamp against a pad or spacer
similarly shaped to the main body and placed within the confines of
the pocket. This retaining structure therefore facilitates
installation and removal of pads or spacer elements relative to the
distal subshell 230.
[0112] The lip and groove 232, 234 conceals edges of any pad or
spacer element retained thereby so as to visually hide the pad or
spacer element, and further protect the edges of the pad or spacer
element. This structure also advantageously makes it so that it is
not necessary to use any fasteners, adhesive or other suitable
means to secure pads or spacer elements to the subshell. The
retaining structure exemplified in FIG. 10 may be extended to any
of the subshells described herein.
[0113] FIG. 11 depicts yet another variation of an orthopedic
component or subshell 240 which includes features that may be used
in any of the subshells described herein. According to this
variation, the subshell 240 is divided into individual shell
portions 241, 242, 243, 244 which are connected to one another via
a connective portion 245 formed from a material similar to the
material used to form the perimeter edge portion in other
embodiments described herein. The shell portions may be formed from
a material similar to the material used to form the main body in
other embodiments described herein. In other words, the shell
portions are formed from a less compressible and tougher material
than the connective portion.
[0114] The connective portion 245, as in the embodiment of FIG. 10,
defines a lip 246 extending over the periphery of each of the shell
portions 241, 242, 243, 244. The lip 246 is spaced above the shell
portions 241, 242, 243, 244, on one side thereof, so as to define a
groove or clearance 247 therebetween effectively forming a
retaining structure or pocket. As with the embodiment of FIG. 10,
the lip and groove 246, 247 can retain and conceals edges of any
pad or spacer element retained thereby so as to visually hide the
pad or spacer element, and further protect the edges of the pad or
spacer element without the requirement of any fasteners, adhesive
or other suitable means to secure pads or spacer elements to the
subshell. It will be pointed out that the composition of the
connective portion is not restricted to materials having less
hardness, but it may actually have a greater rigidity or hardness
than the shell portions.
[0115] Also depicted in FIG. 11 is a tibial recessed portion 248
which is defined generally at a location corresponding to the
wearer's tibia. This recessed portion 248 comprises only the softer
and more resilient material forming the connective portion 248. It
follows that this section has a transitional, beveled section 249
leading to a portion of decreased thickness as compared to portions
of the subshell having the combination of the shell portions and
connective portion. This recess allows for greater cushioning and
compliance about the tibia, similar to the concept used in
accordance with the embodiment of FIG. 4. As with the retaining
structure for a pad or spacer element, the recessed portion is
preferably located on a side of the subshell which is located
adjacent to the leg of the wearer. It will be pointed out that the
recessed portion is not restricted to corresponding to the tibia of
the wearer, but the concept of the recessed portion may be extended
or placed to any location considered appropriate.
[0116] Turning to another embodiment of an orthotic shell employing
features found in part by the variations of FIGS. 10 and 11, the
orthotic shell 250 of FIG. 12 exemplifies a shell construction
wherein shell bodies 252, 254 are connected by connective portion
256. As with the embodiments of FIG. 11, the connective portion 256
forms a lip 257 which extends over the shell bodies 252, 254 and is
spaced over such shell bodies 252, 254 on one side thereof to form
a groove or clearance 258. The orthotic shell 250 is particularly
in the brace described in U.S. patent application publications
2006/0135900 and 2007/0185425.
[0117] The lip 257 extends on one side of the shell 250 so that the
clearance 258 defines the extension of the lip 257 relative to a
central portion 260 of the connective portion 256. In other words,
the central portion 260 is thinner than at the lip 257. It may also
be configured thinner than the shell bodies since these shell
bodies do not directly connect to one another; they are preferably
connected only by the connective portion 256. The central portion
260 may correspond similarly to the tibial recessed portion 248 in
FIG. 11 so as to relieve pressure at a particular portion of the
tibia.
[0118] The connective portion 256 may be formed from similar
materials as the perimeter edge portion of the embodiment of FIG.
10 or the connective portion of the embodiment of FIG. 11.
Similarly, the shell portions 252, 254 may be formed from similar
materials as the shell portions of the embodiment of FIG. 11.
[0119] It will be pointed out that while it is explained that the
shell portions in FIGS. 11 and 12 do not directly connect to one
another, the shells of the embodiments of FIGS. 11 and 12 may be
configured so that shell portions are directly connected to one
another or are formed continuously with one another. In the event
the shell portions were continuously formed with one another as a
single body portion, the central portion or recessed portion may be
formed such that the single shell portion has a reduced thickness
in comparison regions outside of such central or corresponding
region.
[0120] FIGS. 13 and 14 exemplify the main body 306 of an embodiment
of a strap retainer 300 prior to receiving a flexible peripheral
edge portion of the type described in connection with the
orthopedic braces 10, 100. In this embodiment, the main body 306
defines inwardly and outwardly facing sides 301, 303. The main body
306 includes a head portion 304 defining an aperture 316, a tail
portion 306 defining a strap slot 308, and a ventilation feature
310, exemplified herein by a slot.
[0121] Reinforcement elements 312, 314 are either integrally formed
or mechanically adhered to the inwardly facing surface 301 of the
main body 302 and provided around at least end regions of the strap
slot 308 and the slot 310. The reinforcement elements 312, 314
strengthen sections of the strap retainer so as to prevent tearing
of the strap retainer and to stiffen the strap retainer at
pre-selected sections. While it is preferred to provide the
reinforcement elements only at the end portions of the strap slot
308 so as to allow the strap retainer to readily flex, other
configurations of reinforcement elements may be used such as those
that extend partially or entirely around any one of the slots or
similar structure of the strap retainers. Moreover, the
reinforcement elements, such as element 314, may be provided at
regions of the strap retainer that are meant to bend, as depicted
in the configuration of FIGS. 15 and 16.
[0122] As shown in FIG. 14, the outwardly facing surface 303 does
not include reinforcement elements. However, it will be understood
that reinforcement elements may be provided on the outwardly facing
surface in configurations similar to those described in connection
with the inwardly facing surface 301.
[0123] While the ventilation feature 310 is shown as a slot, the
ventilation feature may assume a variety of configurations that do
not significantly hinder the flexibility and strength of the strap
retainer. Some configurations include a plurality of apertures,
slots, and other suitable shapes, sizes and combinations thereof.
Moreover, the ventilation feature need not include corresponding
reinforcement elements.
[0124] The strap retainer 300 is depicted in FIGS. 15 and 16 with a
peripheral edge portion 318 of the type described above in
connection with the embodiments of braces 10, 100. The strap
retainer 300 also includes a fastener guard 320 with flexion
features 322 that cover a fastener when the strap retainer 300 is
secured to a frame of the orthopedic device.
[0125] In FIGS. 15 and 16, the strap retainer 300 is formed in a
curved configuration which may represent the strap retainer 300 as
either in a condition wherein it is molded so as to curve, or so
that it represents the strap retainer 300 when it is flexed about
the leg of the wearer due to the securing of a strap between
lateral and medial strap attachments.
[0126] The fastener guard 322 serves to protect the leg of the
wearer of the orthopedic brace from any hard or sharp edges of the
fastener. It also has cushioning and flexible properties similar to
the peripheral edge portion 318. The fastener guard 320 allows for
the strap retainer 300 to be mounted on the inwardly facing side of
the frame without causing discomfort to the wearer of the
orthopedic brace. The flexion feature 322 permits the fastener to
be removed from the strap retainer and frame without destroying the
strap retainer.
[0127] The fastener guard 320 may be formed from the same material
that is used as the peripheral edge portion 318, and may be
integrated with the main body 302 when the peripheral edge portion
318 is molded onto the main body. Alternatively, the fastener guard
320 may be formed from the same material as the main body 302, or
from a different material from the peripheral edge portion 318 and
the main body 302. Alternatively, the fastener guard 302 may be
mechanically adhered to the main body 302.
[0128] While the strap retainer is described and shown herein in a
particular geometry, it will be understood that the strap retainer
may be configured in a variety of configurations. However, any such
configurations must provide means for securing a strap thereto, and
means for pivotably securing the strap retainer to the frame of a
brace.
[0129] In observing FIG. 17, a strap pad 350 may be provided that
has a shape generally corresponding to the shape of the strap
retainer 300. The strap pad 350 includes a main body 352
corresponding to the main body 304, a recessed head 354 that
accommodates the fastener guard 320, a slot 358 that accommodates
the ventilation feature 310, and a recessed tail 356 that
accommodates the strap slot 308. While not shown, the strap pad 305
may also include recesses or depressions that can accommodate the
reinforcement elements, and perforations by way of its inherent
material composition or mechanical perforations.
[0130] The strap pad 350 is secured to the inwardly facing surface
301 of the strap retainer 300 so as to be proximate to the leg of
the wearer of the orthopedic brace. The strap pad 350 may be
mechanically adhered to the strap retainer 300, or removably
secured via hook and loop fastener elements or other suitable
elements.
[0131] The orthopedic brace may include fastener retainers
integrated or secured within the shell, as depicted in FIGS. 18-20,
for securing the strap retainers, subshells, and straps to the
frame. For example, in FIG. 1, the strap 62 may have one end
directly secured to the upper proximal-lateral support via a
fastener 88 that is received by a fastener retainer (not
shown).
[0132] In accordance with one embodiment, the fastener retainer 408
is press fitted into the frame 404 from the outwardly facing side
so that an orifice 416 of the fastener retainer 408 is exposed on
the inwardly facing side of the frame 404. A recess 406 may be
formed within the frame thickness so as to accommodate the fastener
retainer 408, or the fastener retainer 408 may be urged through the
frame while the composite material cures. Upon curing of the
composite material, the outwardly facing surface of the frame 404
is treated with a covering material, primer and paint (collectively
represented as 402) so as to cover the fastener retainer 408 from
the outwardly facing side.
[0133] In another embodiment, the fastener retainer 408 is
laminated within the frame 404 thereby forming a region 406 wherein
the fastener retainer 408 is contained. The fastener retainer 408
is effectively embedded within the frame 404 with only its orifice
416 being exposed along the inwardly facing side of the frame
404.
[0134] As shown in detail in FIG. 12, the fastener retainer 408
includes the orifice 416 leading to a threaded portion 414, flanged
head 410, and an outer surface 412 including a plurality of cleats
418 extending therefrom. The cleats 418 serve to lock the fastener
retainer 408 within the thickness of the frame 404, and to prevent
the fastener retainer 408 from loosening from the inwardly facing
surface of the frame 404.
[0135] The fastener retainer 408 prevents the need for any
protuberances extending from either the inwardly or outwardly
facing surfaces. In other words, any fasteners are preferably
maintained in a low profile manner so as to minimize or avoid any
hard areas on the brace that may discomfort the wearer, or snag on
clothing or other items that the brace may come into contact with.
Moreover, such a low profile also contributes to an overall
aesthetic appearance that conceals many of the fasteners used to
secure the various subshells, straps and strap retainers of the
brace.
[0136] The fastener retainer may be constructed from a variety of
materials such as metals and plastics that can withstand repeated
securing of fasteners. Furthermore, the fastener retainer must be
constructed from a material that will assure that the cleats remain
embedded or secured with the frame.
[0137] In another embodiment in accordance with the invention, the
brace may include a patella protector assembly using the concepts
described above in accordance with the embodiments of FIGS.
1-16.
[0138] In observing FIGS. 21-23, the orthopedic brace of FIG. 6 is
shown including an orthopedic component in the form of a patella
protector assembly 500. This assembly 500 includes an upper shell
508 and a lower shell 510 which are slidably and telescopically
connected to a central shell 501 so as to cover the patella of a
wearer and to leave no gap between any of the three shells 501,
508, 510. The central shell 501 is connected at the hinge of the
brace, whereas the upper and lower shells 508, 510 are connected
via extension portions 512, 514 or elastic elements (not shown),
respectively, to upper and lower frame elements of the brace. Thus,
as the leg moves, the central shell 501 moves relative to the upper
and lower shells 508, 510 so as to accommodate flexion of the leg
as the central shell 501 generally remains in place over the knee
and hence the patella.
[0139] For example, as shown in FIG. 25, the wearer has a knee in
an extended position wherein the upper shell 508 is partially
concealed under the central shell 501, and the lower shell 510 is
likewise partially concealed under the central shell 501. When the
knee is in flexion, as shown in FIG. 26, the upper shell 508 slides
away from the central shell 501, and the lower shell likewise
slides away from the central shell 501. In each position, and
throughout the range of motion of the knee, the patella protector
assembly provides protection of the patella and portions of the leg
thereabout while accommodating movement of the knee and leg.
[0140] The connection of the upper and lower shells 508, 510 to the
central shell 501 is generally concealed so as to minimize any
parts extending from the patella protector assembly that may break
or catch on anything. For example, the connection of the upper and
lower shells 508, 510 to the brace frame elements is provided by
way of the extension elements 512, 514 which are secured to an
inner side of the frame assemblies of the brace by suitable
fasteners such as rivets or hook and loop systems. These extension
elements 512, 514 are generally contoured to accommodate the shape
of corresponding section of the leg. The extension elements 512,
514 extend underneath or connect to the interior side of the frame
assemblies of the brace so as to hide any fasteners. Likewise, as
will be explained below, the connection of the upper and lower
shells to the central shell is concealed so as to avoid exposing
any connecting elements or fasteners that may be damaged from any
impact during use of the patella protector assembly.
[0141] As depicted in FIGS. 22 and 23, the assembly 500 includes
padding liners 524, 525, 526 which correspond to the shells 501,
508, 510, respectively. The liners are formed with contours 528
which accommodate the leg anatomy. The liners may be secured to the
shells in accordance with known fasteners or adhesives, or
alternatively the shells may be formed similarly to the embodiments
of FIGS. 10-12 which include means to accommodate liners without
the necessity of fasteners or adhesives. The shells and the liners
hence are formed to closely follow the contours of the leg so as to
maintain a streamlined and unobtrusive configuration which
minimizes interference from apparel and equipment that may be used
when the brace and assembly are worn together.
[0142] The liners may be constructed from open celled foam, such as
EVA foam, so as to provide superior shock absorbing properties. The
inner surface (surface adjacent the leg anatomy of the wearer) of
the liner may include a layer material such as suede, nylon or
other material selected for comfort and durability. The outer
surface of the liner may include a layer of loop material and the
inner surface of the shells may include suitable hook structure for
engaging the loop material.
[0143] As illustrated in FIGS. 21 and 23, the central shell 501
includes a rigid main shell 502 and a more flexible perimeter edge
portion 504 extending about the periphery of the main shell 502 is
secured. This construction of the main shell 502 and the perimeter
edge portion 504 is similar to that of the subshells in accordance
with the embodiment of FIGS. 1-3 wherein the perimeter edge portion
has greater flexibility than the top shell.
[0144] Unlike the aforementioned subshells in other embodiments
described herein, the main shell is preferably more rigid and
tougher than the subshells, and further the perimeter edge portion
may likewise be formed from a tougher material that is resilient
and not rigid like the main shell. For example, the main shell may
be constructed from a blend of polyamide and ABS, such as the
commercial product TERBLEND sold by BASF, so as to provide
excellent impact strength, high surface quality, easy processing,
chemical resistance, heat resistance and a pleasant feel. On the
other hand, as with materials used in the aforementioned subshells,
the perimeter edge portion may be constructed from thermoplastic
polyurethane, such as ELASTOLLAN.
[0145] The perimeter edge portion 504 preferably extends about the
entirety of the periphery of the main shell 502 so as to provide a
compliant edge, and so as to secure to the brace via a resilient
connection. The resilient connection is preferably defined by
opposed wings 516 extending laterally relative to the central shell
and are arranged for preferably securing about the hinge of the
knee brace. Each wing 516 has an opening 518 configured for
securing about a hinge, thereby permitting the insertion of the
wing 516 between hinge plates of a hinge so as to clamp it to the
brace. The opening 518 also may accommodate a condyle pad which may
be secured to the hinge (as in pad 184 in FIG. 4).
[0146] Because the perimeter edge portion 504 is formed from a
substantially resilient material, it can withstand twisting of the
knee and still support the main body relative to the hinges. This
is advantageous when the brace is used for sports in that the
patella protector assembly can, while overall providing resistance
and protection, accommodate minor movements or shifting of the knee
while still covering the knee. This further provides comfort to the
wearer in that the perimeter edge portion allows for a more
comfortable fitting about the knee while the central shell still
provides sufficient protection by way of the rigid top shell.
[0147] The upper and lower shells 510, 512 are constructed
similarly to the central shell 501, in that each of the shells 510,
512, includes a main body 511, 513, the extensions 513, 514,
respectively, and include a perimeter edge portion 533, 534,
respectively. These shells can be formed from the same
aforementioned materials used for forming the central shell.
[0148] The central shell 501 has an arcuate cross-section which is
generally contoured to accommodate the patella portion of the
anterior knee. The upper and lower shells 510, 512 are
correspondingly contoured in cross-section to generally permit
pivoting of at least 90.degree. relative to and from one end
connected to the central shell without interference by the central
shell. Moreover, and quite advantageously, the contour of the upper
and lower shells closely corresponds to the central shell so as to
minimize gaps between the shells upon extension and flexion of the
knee, and thus movement of the shells relative to one another.
[0149] This unique cooperation and configuration among the shells
imparts superior articulation of the shells relative to one
another. The cooperation and configuration allows the assembly to
afford protection of knee while allowing for an ease of movement
among the shells and comfort to the wearer without hindering
performance of the wearer in movement of the knee. Advantageously,
the concepts of the patella protector assembly may be extended to a
variety of suitable other configurations to protect other anatomy
other than a knee.
[0150] As with the aforementioned subshells, the central shell 501,
and the upper and lower shells 510, 512 define a ventilation
feature 522, formed by way of a plurality of apertures that are
arranged in a predetermined pattern. The ventilation feature may be
used in combination with the liners 524, 525, 526, of the type
described above, thereby providing the same benefits of the
aforementioned subshells. The liners may form nubs 531 which extend
through the apertures of the ventilation feature 522.
[0151] The main shell 502 includes a plurality of elongate ribs 520
protruding outwardly from a front surface thereof These ribs 520
may be formed from the same material as the main shell 502, or may
be formed from a different material (having different toughness and
impact resistance) and molded directly onto the top shell in areas
thereof of increased thickness. These ribs 520 are advantageous in
that they serve to reinforce the main body and deflect impact
thereby assisting in the prevention of damaging of the top
shell.
[0152] The central shell 501 forms elongate slots 535, 536 which
extend in the longitudinal direction thereof. These elongate slots
535, 536 open to both the front and rear surfaces of the central
shell 501, and are arranged to accommodate shell retention elements
belonging to the upper and lower shells, as will be discussed
below. The slots 535, 536 also correspond to slots 537, 539 formed
in the liner 524, as depicted in FIG. 23. Along the front surface,
the central shell 501 forms an elongate recess 564 into which the
slots 535, 536 open into.
[0153] The elongate recess 564 is arranged to accommodate a
buttress 506 that protrudes outwardly from the front surface of the
main shell 502 and generally spans the longitudinal length of the
main shell 502. The buttress 506 is preferably formed from a
material that is tougher than the main shell 502 so as to provide
improved impact resistance at the center of the patella protector
assembly. Since the material used to form the buttress may have a
greater weight, the size and location of the buttress may be
limited so as to allow for lighter weight materials to be used for
the main body thereby providing a lightweight patella protector
assembly.
[0154] As illustrated in FIG. 24, the buttress 506 defines a
plurality of nubs 556 which engage notches 538 formed along the
recess 564 of the main shell 502. This allows for the buttress 506
to be separately formed from the main shell 502 and inserted into
the recess 564. In the alternative, the buttress 506 may be
directly molded or inserted into the central shell 501 whereby by
the nubs 556 interlock with the notches 528. The buttress 506 also
defines a plurality of ribs 558 serving a similar function to the
ribs 520 formed on the central shell 501. Further, while the
buttress 506 extends outwardly from the front surface of the top
shell, the peripheral edges 554 of the buttress 506 are preferably
beveled so as to minimize sharp edges and provide greater impact
resistance.
[0155] Each of the upper and lower shells 508, 510, has a shell
retention element 530, 532. Each shell retention element 530, 532
defines a generally arcuate neck 542, 548 formed along an end
portion proximate to the central shell. A cross-bar 540, 550 is
formed from each of the necks 542, 548, respectively.
[0156] The cross-bars 540, 550 are formed so as to slidably engage
the front surface area around the slots 535, 536 of the central
shell 501. Thus, the cross-bars 540, 550 have a width greater than
the slots 535, 536. The necks 542, 548 thus have a height that is
minimally greater than the combined thickness of the central shell
501 and the liner 524 since the necks 542, 548 effectively are
located within the slots 535, 536, 537, 539 so as to permit the
cross-bars 540, 550 to engage and slide relative to the slots 535,
536 and extend into the recess 564.
[0157] FIG. 24 shows the back surface of the buttress 506 wherein
opposed recesses 566, 568 are defined and have a width greater than
a width of the cross-bars 540, 550. Limits 570 are likewise formed
to prevent sliding of the cross-bars 540, 550 in a first direction
(extension of the assembly), and limits 571 prevent sliding of the
cross-bars 540, 550 in second direction (flexion of the assembly).
The recesses 566, 568 effectively combine with the recess 564 to
control sliding of the cross-bars 540, 550.
[0158] From the shape of the neck and cross-bars of each shell
retention element, the upper and lower shells are able to pivotably
articulate, via particularly the shape of the arcuate neck, to
accommodate movement of the knee as such shells slide relative to
one another as the knee goes between extension and flexion. In
other words, the upper and lower shells are able to rotate at the
shell retention elements relative to the central shell. Thus, not
only do the shells slide relative to one another, rotational
movement is permitted which allows the wearer of the assembly to
articulate the knee without hindrance while affording the necessary
protection.
[0159] It will be pointed out that certain features of the assembly
may be replaced by elastic elements. For example, the shell
extensions may be replaced by or connect to the frame assemblies of
a brace via elastic elements. Alternatively, the shell retention
elements may be replaced with elastic elements which connect the
upper and lower shells to the central shell.
[0160] While the foregoing embodiments have been described and
shown, it is understood that alternatives and modifications of
these embodiments, such as those suggested by others, may be made
to fall within the scope of the invention.
* * * * *